NCT07159282 · Applied Biologics, LLC
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
What this study is about
A conducted at multiple hospitals, forward-looking, controlled clinical trial evaluating the effectiveness of a single layer placental-based allograft and the usual treatment in the management of nonhealing diabetic foot ulcers.
View original scientific description
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The potential subject must be at least 18 years of age or older.
- The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- The potential subject must consent to using the prescribed offloading method for the duration of the study.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.
Exclusion criteria
- The potential subject is known to have a life expectancy of \< 6 months.
- The potential subject's target ulcer is not secondary to diabetes.
- The target ulcer is infected or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- There is evidence of osteomyelitis complicating the target ulcer.
- There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
- The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.
- The potential subject participated in the CAMPX trial and achieved complete closure.
Where
- Hollywood, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations